IRLAB Therapeutics: FDA thumbs up to mesdopetam’s Phase III plan - Edison

IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now engage with European regulatory agencies to prepare for the Phase III trial. Following the positive endorsement from the FDA, we expect partnering talks to intensify in the coming weeks, with the partner taking on responsibility for further clinical development.

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Länk till analysen i sin helhet: https://www.edisoninvestmentresearch.com/research/report/irlab-therapeutics849465/preview